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Safety and Metabolic Effects of Tesamorelin, a Growth Hormone-Releasing Factor Analogue, in Patients with Type 2 Diabetes: a Randomized, Placebo-Controlled Trial

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Safety and Metabolic Effects of Tesamorelin, a Growth Hormone-Releasing Factor Analogue, in Patients with Type 2 Diabetes: a Randomized, Placebo-Controlled Trial RESEARCH ARTICLE Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial David R. Clemmons1*, Sam Miller2, Jean-Claude Mamputu3 1 Division of Endocrinology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, a1111111111 North Carolina, United States of America, 2 SAM Clinical Research Center, San Antonio, Texas, United States of America, 3 Theratechnologies Inc., Montreal, Quebec, Canada a1111111111 a1111111111 * [email protected] a1111111111 a1111111111 Abstract OPEN ACCESS Objective Citation: Clemmons DR, Miller S, Mamputu J-C Use of growth hormone is associated with side effects, including insulin resistance. The (2017) Safety and metabolic effects of tesamorelin, objective of this study was to determine whether tesamorelin, a stabilized growth hormone- a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, releasing hormone analogue, would alter insulin sensitivity or control of diabetes. placebo-controlled trial. PLoS ONE 12(6): e0179538. https://doi.org/10.1371/journal. pone.0179538 Design Editor: Noel Christopher Barengo, Florida A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes. Three International University Herbert Wertheim College treatment groups: placebo, 1 and 2 mg tesamorelin. of Medicine, UNITED STATES Received: September 7, 2016 Measurements Accepted: May 25, 2017 Fasting glucose, glucose and insulin from oral glucose tolerance test, glycosylated hemo- Published: June 15, 2017 globin (HbA1c), home blood glucose, insulin-like growth factor-1, and lipids. Copyright: © 2017 Clemmons et al. This is an open access article distributed under the terms of the Main outcome measure Creative Commons Attribution License, which permits unrestricted use, distribution, and Relative insulin response following oral ingestion of glucose. reproduction in any medium, provided the original author and source are credited. Results Data Availability Statement: All relevant data are within the paper and its Supporting Information No significant differences were observed between groups in relative insulin response over files. the 12-week treatment period. At Week 12, fasting glucose, HbA1c and overall diabetes con- Funding: Theratechnologies Inc. sponsored the trol were not significantly different between groups. In addition, relevant modifications in dia- study and provided support in the form of salary betes medications were similar between groups. Total cholesterol (-0.3±0.6 mmol/L) and for author JCM. DRC was a paid consultant of non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in Theratechnologies Inc. at the time the study was performed. SM has no relevant financial disclosure. the tesamorelin 2 mg group (p<0.05 vs. placebo). No patient discontinued the study due to Theratechnologies did not have any additional role loss of diabetes control. PLOS ONE | https://doi.org/10.1371/journal.pone.0179538 June 15, 2017 1 / 16 Safety and metabolic effects of tesamorelin in patients with type 2 diabetes in the study design, data collection and analysis, Conclusions decision to publish, or preparation of the manuscript. The specific roles of these authors are Treatment of type 2 diabetic patients with tesamorelin for 12 weeks did not alter insulin articulated in the "author contributions" section. response or glycemic control. Competing interests: We have the following interests. Theratechnologies Inc. sponsored the Trial registration study. Jean-Claude Mamputu is employed by ClinicalTrials.gov NCT01264497. Theratechnologies Inc. David R Clemmons has received fees for consultancy from Theratechnologies Inc. at the time the study was performed. There are no patents, products in development or marketed products to declare. This Introduction does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed Recombinant human growth hormone (rhGH) replacement therapy has been shown to online in the guide for authors. reverse several metabolic alterations associated with low serum GH level or GH deficiency, including increased visceral adipose tissue (VAT), altered lipid profile, and impaired physical performance [1±3]. However, administration of pharmacological doses of rhGH is associated with a variety of adverse effects, including hyperglycemia, insulin resistance, fluid retention, and carpal tunnel syndrome [3±4]. In contrast, strategies using growth hormone-releasing fac- tor (GRF)/growth hormone-releasing hormone (GHRH) analogues to induce physiological increases of GH and preserve the insulin-like growth factor-1 (IGF-1) negative feedback have been shown to correct metabolic abnormalities and body composition changes associated with low GH levels with fewer side effects, particularly with regard to hyperglycemia [5±8]. Tesamorelin (Theratechnologies, Inc., Montreal, Quebec, Canada) is a synthetic analogue of human GHRH that increases basal and pulsatile secretion of GH [9±10]. A hexenoyl moiety has been anchored at the N-terminus of the 44 amino acid sequence of human GHRH, result- ing in enhanced stability in serum as compared to natural human GHRH. Because GH has been shown to worsen glucose tolerance in some subjects, including those receiving highly active antiretroviral therapy (HAART) [11], a randomized, parallel, placebo-controlled, multi- center study was carried out to assess the safety of tesamorelin in only subjects with type 2 dia- betes mellitus. Methods The protocol for this study and supporting CONSORT checklist are available as supporting information: see S1 CONSORT checklist and S1 Protocol. Study design Patients with stable type 2 diabetes were recruited at 5 sites in the US between February and November 2002. After screening and a 14-day lead-in period to establish and characterize daily dietary patterns and blood measurements, patients diabetes were randomly assigned to receive either placebo, tesamorelin 1 mg, or tesamorelin 2 mg, administered by subcutaneous injection for 12 weeks (Fig 1). The study included a 4-week follow-up period to monitor for adverse events. Randomization was stratified on the basis on insulin use. To maintain balance of treatment assignments among insulin use groups (insulin use, no insulin use), eligible patients were randomly allocated in balanced blocks (1:1:1 ratio) to one of the 3 treatment groups according to computer generated randomization codes, which were prepared by a stat- istician who was not otherwise involved in the study. Patients and investigators were unaware of assignments to study groups. Tesamorelin and matching placebo were provided as lyophi- lized powder for reconstitution in sterile water. Inclusion criteria included: male or postmeno- pausal or surgically sterilized female subjects, 50 years of age; diagnosis of type 2 diabetes for PLOS ONE | https://doi.org/10.1371/journal.pone.0179538 June 15, 2017 2 / 16 Safety and metabolic effects of tesamorelin in patients with type 2 diabetes Fig 1. CONSORT flow diagram of the clinical study. Patient enrollment and outcomes. https://doi.org/10.1371/journal.pone.0179538.g001 3 months before screening; on stable diabetes treatment regimens (oral hypoglycemics with or without insulin) for 2 months before screening; screening and pre-randomization HbA1c <10% (baseline range: 5.3±9.5%) and body mass index (BMI) between 25 and 38 kg/ m2. Exclusion criteria included: positive mammography (if female) or prostate-specific antigen (PSA) or prostate examination for cancer (if male); use of oral or parenteral glucocorticoids in the 30 days before screening; use of any experimental or marketed GH, GH secretagogue, IGF- 1, or insulin-like growth factor binding protein-3 (IGFBP-3) in the previous 6 months; history of or presence of active concomitant conditions or diseases; documented hypopituitarism, his- tory of pituitary tumor/surgery, head irradiation, or severe head trauma; and current or history of cancer. Metabolic measurements Fasting blood samples were drawn at baseline and at Weeks 1, 4, 8, and 12 of treatment for measurement of fasting glucose and IGF-1 levels. Samples were drawn at baseline and at Weeks 8 and 12 for determination of triglyceride, total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol levels. Fasting blood sam- ples were drawn at baseline and at Weeks 4, 8, and 12 for determination of glycosylated hemo- globin (HbA1c) level. An Oral Glucose Tolerance Test (OGTT) using 75 grams of glucose was performed at baseline and after 1, 4, 8, and 12 weeks of treatment. The subjects had fasted overnight prior to the OGTT. Paired insulin and glucose measurements were performed at 0 minute (before ingestion of 75 grams of glucose) and every 30 minutes during the OGTT. Patients were instructed to withhold insulin and sulfonylurea hypoglycemic medications on PLOS ONE | https://doi.org/10.1371/journal.pone.0179538 June 15, 2017 3 / 16 Safety and metabolic effects of tesamorelin in patients with type 2 diabetes the days in which OGTT was performed. Insulin sensitizers were not withheld. Home blood glucose was obtained four times per day (before breakfast, lunch, and dinner, and at bedtime) using a standard blood glucose meter. The glucose values were downloaded into a computer- ized recall system. The measurements were used to calculate mean daily blood glucose values. In addition, the number
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